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Tokai Pharmaceuticals Reports Fourth Quarter and Full Year 2014 Financial Results
CAMBRIDGE, Mass., March 12, 2015 Tokai Pharmaceuticals, Inc. (NASDAQ: TKAI), a clinical-stage biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally driven diseases, today reported company highlights and financial results for the quarter and year ended December 31, 2014.
We are excited by the recent heightened attention on AR-V7 in prostate cancer and interest in our ARMOR3-SV galeterone registration trial at the 2015 Genitourinary Cancers Symposium (ASCO-GU), stated Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. We remain on track to begin ARMOR3-SV in the first half of the year as we work to complete development of our AR-V7 clinical trial assay and continue trial center start up. We ended 2014 with over $105 million in cash, which we expect will provide us with sufficient funding into 2017, enabling us to take galeterone as a wholly-owned worldwide asset through topline data due by late 2016.
Recent Business Highlights
|||Presented ARMOR3-SV Poster and Supported ASCO-GU CME Event: At the 2015 Genitourinary Cancers Symposium (ASCO-GU) on February 26-27, Tokai presented the protocol and rationale for the ARMOR3-SV Phase 3 trial and supported a CME event discussing AR-V7 in prostate cancer.|
|||Announced Selection of AR-V7 Assay and Companion Diagnostic Development Partner: In January 2015, Tokai announced that it had obtained an exclusive, worldwide license from the Johns Hopkins University related to patent applications and know-how covering an assay that has been used to determine the AR-V7 status of prostate cancer patients for use with galeterone and announced a collaboration with Qiagen to develop a non-invasive AR-V7 companion diagnostic for use with galeterone. Qiagen initiated development of the AR-V7 assay as a companion diagnostic in October 2014 and the Company expects the AR-V7 assay to be available for use for its planned ARMOR3-SV trial in the first half of 2015.|
|||Expanded Board of Directors: During the first quarter of 2015, Tokai announced the appointment of Stephen Buckley, Jr. to its board of directors.|
|||Reported Interim Results from Ongoing ARMOR2 Trial: At the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in November 2014, Tokai presented updated interim results from the ongoing Phase 2 ARMOR2 trial evaluating galeterone as a treatment for patients with castration-resistant prostate cancer (CRPC). Data demonstrating PSA50 reductions, time to PSA progression and duration of therapy suggests efficacy in patients with C-terminal loss, a segment of the population linked to poor responsiveness to hormonal agents commonly used to treat CRPC.|
The following information was filed by Tokai Pharmaceuticals Inc (TKAI) on Wednesday, March 18, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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